BreastfeedingPREPARENCT04258709
PRenatal Video-Based Education and PostPARtum Effects
A study testing AME and Video-based infant care education in people with Breastfeeding, run by University of Pittsburgh at 1 site in United States.
Trial summary
The purpose of this randomized controlled trial is to examine the impact of a remotely-delivered antenatal milk expression (AME) intervention versus an attention control condition on breastfeeding outcomes among a sample of 280 nulliparous, non-diabetic women with pre-pregnancy body mass indices ≥ 25. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breastfeeding
- What is being tested?
- AME and Video-based infant care education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 280 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Sep 2020to 29 Nov 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Pregnant women who:
- have a pre-pregnancy BMI ≥ 25
- are ≥ 18 years
- are English-speaking
- are 34 0/7-36 6/7 gestational weeks
- are nulliparous
Show all 9Show fewer
- intend to/have interest in breastfeeding after birth
- are having a singleton pregnancy
- plan to receive prenatal care and deliver at select hospital/birth facility systems (access to EMR data)
Who cannot join
- contraindications to breastfeeding as specified by the American Academy of Pediatrics
- history of breast reduction surgery or radiation
- indication for delivery by 37 weeks gestation
- gestational or pre-existing diabetes
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Pittsburgh
Pittsburgh, Pennsylvania, 15213
About this study
Official title: Effect of Antenatal Milk Expression on Breastfeeding Outcomes Among Overweight and Obese Women
The purpose of this randomized controlled trial is to examine the impact of a remotely-delivered antenatal milk expression (AME) intervention versus an attention control condition on breastfeeding outcomes among a sample of 280 nulliparous, non-diabetic women with pre-pregnancy body mass indices ≥ 25. AME involves milk expression and collection in the third pregnancy trimester and is theorized to address multiple barriers to breastfeeding among women with higher BMI, including impaired breastfeeding self-efficacy, insufficient milk supply (critical period endocrine modulation of milk volume), and early formula supplementation in the context of a medically complex birth (availability of banked antenatal milk).
Participants will be enrolled in their third trimester of pregnancy and allocated into one of two study arms: 1) AME instruction delivered by remote, live International Board Certified Lactation Consultants via an innovative app-based telelactation platform; or 2) an attention control condition (video-based infant care education unrelated to infant feeding). Video-based education for both groups will occur in weekly study visits from 37 to 40 weeks gestation, with women in the intervention group continuing AME 1-2 times per day at home.
Measured outcomes of interest will include short and long-term breastfeeding practices (e.g., breastfeeding duration, exclusivity) and participants' experiences with and perceptions of AME.
Read the detailed description
The purpose of the PREPARE Trial is to examine the impact of an antenatal milk expression (AME) intervention among women with pre-pregnancy BMI 25 or more on breastfeeding outcomes, including breastfeeding self-efficacy, breastfeeding duration and exclusivity, and perception of insufficient milk supply. Specifically, the investigators will:
- Determine the effect of the AME intervention on short-term breastfeeding outcomes, including breastfeeding self-efficacy and exclusivity, to two weeks postpartum.
- Explore the sustained effect of the AME intervention on longer-term breastfeeding duration and exclusivity over the first year postpartum.
- Examine participants' experiences with and perceptions of AME.
- Conditions
- Breastfeeding
- Being tested
- AME, Video-based infant care education
- Keywords
- antenatal milk expression, antenatal colostrum
- Medical subject headings
- Breast Feeding
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AMEBehavioural
Participants receive education on AME and feedback on technique with a remotely-based IBCLC via live streaming video.
Video-based infant care educationBehavioural
Participants view a standard set of web-based streamed videos addressing evidence-based infant care, unrelated to feeding/breastfeeding.
| Study group | Role | What they receive |
|---|---|---|
| Antenatal Milk Expression (AME) Intervention Group | Experimental | Weekly video interactions (weeks 37-40 of pregnancy) with International Board Certified Lactation Consultants (IBCLCs) to teach and reinforce antenatal milk expression. At-home practice of hand expression and collection of any expressed milk. Receives: Behavioral: AME |
| Video-based Infant Care Education Control Group | Active comparator | Weekly video education (weeks 37-40 of pregnancy) on various topics related to infant care (e.g., safe sleep, car seat safety, etc.). Receives: Behavioral: Video-based infant care education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Breastfeeding Exclusivity
Whether participant is feeding 100% breast milk at 2 weeks postpartum
Measured: 2 weeks postpartum
Breastfeeding Self-efficacy
Score on Breastfeeding Self-Efficacy Scale-SF (score range 14-70, with higher score represents better outcome)
Measured: 2 weeks postpartum
Secondary outcomes (26)
Number of Participants Exclusively Breastfeeding During Postpartum Hospitalization
This variable was derived from the infant's feeding documentation via Electronic Medical Record. Responses for Breastfeeding Exclusivity were categorized as YES if the infant had been fed only their mother's own breast milk. Responses were categorized as NO if they had received anything other than only their mother's own breast milk (e.g., formula + their own milk, formula only).
Measured: Postpartum hospitalization (0-4 days postpartum)
Number of Participants Exclusively Breastfeeding at 2 Weeks Postpartum
This variable derived from participant self-report survey emailed at 2 weeks postpartum. Responses for Breastfeeding Exclusivity were categorized as YES if the infant had been fed only their mother's own breast milk. Responses were categorized as NO if they had received anything other than only their mother's own breast milk (e.g., formula + their own milk, formula only).
Measured: 2 weeks postpartum
Number of Participants Exclusively Breastfeeding at 6 Weeks Postpartum
This variable derived from participant self-report survey emailed at 6 weeks postpartum. Responses for Breastfeeding Exclusivity were categorized as YES if the infant had been fed only their mother's own breast milk. Responses were categorized as NO if they had received anything other than only their mother's own breast milk (e.g., formula + their own milk, formula only).
Measured: 6 weeks postpartum
Number of Participants Exclusively Breastfeeding at 12 Weeks Postpartum
This variable derived from participant self-report survey emailed at 12 weeks postpartum. Responses for Breastfeeding Exclusivity were categorized as YES if the infant had been fed only their mother's own breast milk. Responses were categorized as NO if they had received anything other than only their mother's own breast milk (e.g., formula + their own milk, formula only).
Measured: 12 weeks postpartum
Number of Participants Exclusively Breastfeeding at 6 Months Postpartum
This variable derived from participant self-report survey emailed at 6 months postpartum. Responses for Breastfeeding Exclusivity were categorized as YES if the infant had been fed only their mother's own breast milk. Responses were categorized as NO if they had received anything other than only their mother's own breast milk (e.g., formula + their own milk, formula only).
Measured: 6 months postpartum
Breastfeeding Exclusivity (Categorical)
Categorical outcome indicating proportional range of breast milk feeds during postpartum/birth hospitalization (0-4 days postpartum)
Measured: 0-4 days postpartum
Breastfeeding Exclusivity (Categorical)
Categorical outcome indicating proportional range of breast milk feeds since infant was born
Measured: 2 weeks
Breastfeeding Exclusivity (Categorical)
Categorical outcome indicating proportional range of breast milk feeds in past week
Measured: 6 weeks postpartum
Breastfeeding Exclusivity (Categorical)
Categorical outcome indicating proportional range of breast milk feeds in past week
Measured: 12 weeks postpartum
Breastfeeding Exclusivity (Categorical)
Categorical outcome indicating proportional range of breast milk feeds in past week
Measured: 6 months postpartum
Breastfeeding Self-efficacy
Scores on Breastfeeding Self-Efficacy Scale-SF(score range 14-70, with higher score represents better outcome)
Measured: 6 weeks postpartrum
Breastfeeding Self-efficacy
Scores on Breastfeeding Self-Efficacy Scale-SF(score range 14-70, with higher score represents better outcome)
Measured: 12 weeks postpartum
Number of Participants Breastfeeding at Postpartum Hospitalization (0-4 Days Postpartum)
This variable was derived from the infant's feeding documentation via Electronic Medical Record. Responses were categorized as YES for Breastfeeding Duration if they answered that they were still feeding their own breast milk to their infant at each respective timepoint. Please note that responses were still classified as a YES if they were combination feeding (e.g., using their own breast milk along with formula, solids, etc.). Responses were categorized as NO if they had ceased to provide any of their own breast milk to their infant.
Measured: Postpartum hospitalization (0-4 days postpartum)
Number of Participants Breastfeeding at 2 Weeks Postpartum
Participants were asked what their infant was currently being fed. Responses were categorized as YES for Breastfeeding Duration if they answered that they were still feeding their own breast milk to their infant at each respective timepoint. Please note that responses were still classified as a YES if they were combination feeding (e.g., using their own breast milk along with formula, solids, etc.). Responses were categorized as NO if they had ceased to provide any of their own breast milk to their infant.
Measured: 2 weeks postpartum
Number of Participants Breastfeeding at 6 Weeks Postpartum
Participants were asked what their infant was currently being fed. Responses were categorized as YES for Breastfeeding Duration if they answered that they were still feeding their own breast milk to their infant at each respective timepoint. Please note that responses were still classified as a YES if they were combination feeding (e.g., using their own breast milk along with formula, solids, etc.). Responses were categorized as NO if they had ceased to provide any of their own breast milk to their infant.
Measured: 6 weeks postpartum
Number of Participants Breastfeeding at 12 Weeks Postpartum
Participants were asked what their infant was currently being fed. Responses were categorized as YES for Breastfeeding Duration if they answered that they were still feeding their own breast milk to their infant at each respective timepoint. Please note that responses were still classified as a YES if they were combination feeding (e.g., using their own breast milk along with formula, solids, etc.). Responses were categorized as NO if they had ceased to provide any of their own breast milk to their infant.
Measured: 12 weeks postpartum
Number of Participants Breastfeeding at 6 Months Postpartum
Participants were asked what their infant was currently being fed. Responses were categorized as YES for Breastfeeding Duration if they answered that they were still feeding their own breast milk to their infant at each respective timepoint. Please note that responses were still classified as a YES if they were combination feeding (e.g., using their own breast milk along with formula, solids, etc.). Responses were categorized as NO if they had ceased to provide any of their own breast milk to their infant.
Measured: 6 months postpartum
Number of Participants Breastfeeding at 12 Months Postpartum
Participants were asked what their infant was currently being fed. Responses were categorized as YES for Breastfeeding Duration if they answered that they were still feeding their own breast milk to their infant at each respective timepoint. Please note that responses were still classified as a YES if they were combination feeding (e.g., using their own breast milk along with formula, solids, etc.). Responses were categorized as NO if they had ceased to provide any of their own breast milk to their infant.
Measured: 12 months postpartum
Onset of Lactogenesis II
Recall of lactogenesis II in post-birth days
Measured: 2 weeks postpartum
Perceived Milk Supply (Continuous)
Score on PIBBS subscale of H \& H Lactation Scale measuring perceived infant satisfaction with breast milk received (score range: 5-35, higher score is better outcome)
Measured: 2 weeks postpartum
Perceived Milk Supply (Continuous)
Score on PIBBS subscale of H \& H Lactation Scale measuring perceived infant satisfaction with breast milk received (score range: 5-35, higher score is better outcome)
Measured: 6 weeks postpartum
Perceived Milk Supply (Continuous)
Score on PIBBS subscale of H \& H Lactation Scale measuring perceived infant satisfaction with breast milk received (score range: 5-35, higher score is better outcome)
Measured: 12 weeks postpartum
Perceived Milk Supply (Dichotomous)
Endorsement of insufficient milk supply via investigator created item (dichotomous outcome)
Measured: 2 weeks postpartum
Perceived Milk Supply (Dichotomous)
Endorsement of insufficient milk supply via investigator created item (dichotomous outcome)
Measured: 6 weeks postpartum
Perceived Milk Supply (Dichotomous)
Endorsement of insufficient milk supply via investigator created item (dichotomous outcome)
Measured: 12 weeks postpartum
Number of Participants Commenting on the Impact/Integration of AME During Pregnancy and Utilization of Antenatally Collected Milk During the Postpartum Period
A subset of participants took place in a qualitative assessment via semi-structured interview. Numbers below represent the number of participants who endorsed each of the following categories during their interview: 1) discussing the impact of the study on their pregnancy/postpartum experience, 2) integration of AME into their daily life, and 3) utilization of antenatal milk during the postpartum period
Measured: 6 weeks postpartum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2020
- Study start23 Sep 2020
- Primary completion13 Dec 2023
- Study completion29 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for BreastfeedingStudies of the same condition, open and under way.
- More trials run by University of PittsburghThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 280 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Principal investigator, Jill R. Demirci, PhD, RN, IBCLC, University of Pittsburgh
- Investigators
- Jill Demirci, PhD, Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04258709
- Sponsor's protocol ID
- STUDY19030116
- Other IDs
- R01HD098186
- Acronym
- PREPARE
- Status last verified
- Feb 2025
- First submitted
- 3 Feb 2020
- Last updated
- 19 Mar 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Raw (subject level) and/or aggregate data will be shared with other investigators as requested after: 1) publication of main findings; 2) removal of identifiers that would permit linkages to individual research participants; and 3) removal of variables that could lead to deductive disclosure of the identity of individuals. Any individual requests for data sharing will be executed in collaboration with the University of Pittsburgh Institutional Review Board to ensure strict adherence to policies for protections of human subjects. In addition, at the conclusion of the study, de-identified data will be submitted to the National Institute of Child Health and Development (NICHD) Data Repository to ensure public availability.
Publications
Demirci JR, Glasser M, Bogen DL, Sereika SM, Ren D, Ray K, Bodnar LM, O'Sullivan TA, Himes K. Effect of antenatal milk expression education on lactation outcomes in birthing people with pre-pregnancy body mass index >/=25: protocol for a randomized, controlled trial. Int Breastfeed J. 2023 Mar 16;18(1):16. doi: 10.1186/s13006-023-00552-6.
PubMed 36927811
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Antenatal Milk Expression on Breastfeeding Outcomes Among Overweight and Obese Women
- ClinicalTrials.gov ID
- NCT04258709
- Acronym / sponsor ID
- PREPARE / STUDY19030116
- Conditions
- Breastfeeding
- Keywords
- antenatal milk expression, antenatal colostrum
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 280 participants (actual)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study start
- 23 Sep 2020 (actual)
- Primary completion
- 13 Dec 2023 (actual)
- Study completion
- 29 Nov 2024 (actual)
- First posted
- 6 Feb 2020 (actual)
- Results
- Posted 19 Mar 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this randomized controlled trial is to examine the impact of a remotely-delivered antenatal milk expression (AME) intervention versus an attention control condition on breastfeeding outcomes among a sample of 280 nulliparous, non-diabetic women with pre-pregnancy body mass indices ≥ 25. AME involves milk expression and collection in the third pregnancy trimester and is theorized to address multiple barriers to breastfeeding among women with higher BMI, including impaired breastfeeding self-efficacy, insufficient milk supply (critical period endocrine modulation of milk volume), and early formula supplementation in the context of a medically complex birth (availability of banked antenatal milk).
Participants will be enrolled in their third trimester of pregnancy and allocated into one of two study arms: 1) AME instruction delivered by remote, live International Board Certified Lactation Consultants via an innovative app-based telelactation platform; or 2) an attention control condition (video-based infant care education unrelated to infant feeding). Video-based education for both groups will occur in weekly study visits from 37 to 40 weeks gestation, with women in the intervention group continuing AME 1-2 times per day at home.
Measured outcomes of interest will include short and long-term breastfeeding practices (e.g., breastfeeding duration, exclusivity) and participants' experiences with and perceptions of AME.
Detailed description
The purpose of the PREPARE Trial is to examine the impact of an antenatal milk expression (AME) intervention among women with pre-pregnancy BMI 25 or more on breastfeeding outcomes, including breastfeeding self-efficacy, breastfeeding duration and exclusivity, and perception of insufficient milk supply. Specifically, the investigators will:
- Determine the effect of the AME intervention on short-term breastfeeding outcomes, including breastfeeding self-efficacy and exclusivity, to two weeks postpartum.
- Explore the sustained effect of the AME intervention on longer-term breastfeeding duration and exclusivity over the first year postpartum.
- Examine participants' experiences with and perceptions of AME.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Antenatal Milk Expression (AME) Intervention Group | Experimental | Behavioral: AMEWeekly video interactions (weeks 37-40 of pregnancy) with International Board Certified Lactation Consultants (IBCLCs) to teach and reinforce antenatal milk expression. At-home practice of hand expression and collection of any expressed milk. |
| Video-based Infant Care Education Control Group | Active comparator | Behavioral: Video-based infant care educationWeekly video education (weeks 37-40 of pregnancy) on various topics related to infant care (e.g., safe sleep, car seat safety, etc.). |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- Pregnant women who:
Key exclusion criteria (4 listed)
- contraindications to breastfeeding as specified by the American Academy of Pediatrics
- history of breast reduction surgery or radiation
- indication for delivery by 37 weeks gestation
- gestational or pre-existing diabetes
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AMEParticipants receive education on AME and feedback on technique with a remotely-based IBCLC via live streaming video. | Behavioural | Antenatal Milk Expression (AME) Intervention Group |
| Video-based infant care educationParticipants view a standard set of web-based streamed videos addressing evidence-based infant care, unrelated to feeding/breastfeeding. | Behavioural | Video-based Infant Care Education Control Group |
Primary outcome
Breastfeeding Exclusivity
Time frame: 2 weeks postpartum
Whether participant is feeding 100% breast milk at 2 weeks postpartum
Breastfeeding Self-efficacy
Time frame: 2 weeks postpartum
Score on Breastfeeding Self-Efficacy Scale-SF (score range 14-70, with higher score represents better outcome)
26 secondary outcomes
Number of Participants Exclusively Breastfeeding During Postpartum Hospitalization
Time frame: Postpartum hospitalization (0-4 days postpartum)
Number of Participants Exclusively Breastfeeding at 2 Weeks Postpartum
Time frame: 2 weeks postpartum
Number of Participants Exclusively Breastfeeding at 6 Weeks Postpartum
Time frame: 6 weeks postpartum
Number of Participants Exclusively Breastfeeding at 12 Weeks Postpartum
Time frame: 12 weeks postpartum
Number of Participants Exclusively Breastfeeding at 6 Months Postpartum
Time frame: 6 months postpartum
Breastfeeding Exclusivity (Categorical)
Time frame: 0-4 days postpartum
Breastfeeding Exclusivity (Categorical)
Time frame: 2 weeks
Breastfeeding Exclusivity (Categorical)
Time frame: 6 weeks postpartum
Breastfeeding Exclusivity (Categorical)
Time frame: 12 weeks postpartum
Breastfeeding Exclusivity (Categorical)
Time frame: 6 months postpartum
Breastfeeding Self-efficacy
Time frame: 6 weeks postpartrum
Breastfeeding Self-efficacy
Time frame: 12 weeks postpartum
Number of Participants Breastfeeding at Postpartum Hospitalization (0-4 Days Postpartum)
Time frame: Postpartum hospitalization (0-4 days postpartum)
Number of Participants Breastfeeding at 2 Weeks Postpartum
Time frame: 2 weeks postpartum
Number of Participants Breastfeeding at 6 Weeks Postpartum
Time frame: 6 weeks postpartum
Number of Participants Breastfeeding at 12 Weeks Postpartum
Time frame: 12 weeks postpartum
Number of Participants Breastfeeding at 6 Months Postpartum
Time frame: 6 months postpartum
Number of Participants Breastfeeding at 12 Months Postpartum
Time frame: 12 months postpartum
Onset of Lactogenesis II
Time frame: 2 weeks postpartum
Perceived Milk Supply (Continuous)
Time frame: 2 weeks postpartum
Perceived Milk Supply (Continuous)
Time frame: 6 weeks postpartum
Perceived Milk Supply (Continuous)
Time frame: 12 weeks postpartum
Perceived Milk Supply (Dichotomous)
Time frame: 2 weeks postpartum
Perceived Milk Supply (Dichotomous)
Time frame: 6 weeks postpartum
Perceived Milk Supply (Dichotomous)
Time frame: 12 weeks postpartum
Number of Participants Commenting on the Impact/Integration of AME During Pregnancy and Utilization of Antenatally Collected Milk During the Postpartum Period
Time frame: 6 weeks postpartum
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 36927811Demirci JR, Glasser M, Bogen DL, Sereika SM, Ren D, Ray K, Bodnar LM, O'Sullivan TA, Himes K. Effect of antenatal milk expression education on lactation outcomes in birthing people with pre-pregnancy body mass index >/=25: protocol for a randomized, controlled trial. Int Breastfeed J. 2023 Mar 16;18(1):16. doi: 10.1186/s13006-023-00552-6.
- Individual participant dataSharing planned: Yes. Raw (subject level) and/or aggregate data will be shared with other investigators as requested after: 1) publication of main findings; 2) removal of identifiers that would permit linkages to individual research participants; and 3) removal of variables that could lead to deductive disclosure of the identity of individuals. Any individual requests for data sharing will be executed in collaboration with the University of Pittsburgh Institutional Review Board to ensure strict adherence to policies for protections of human subjects. In addition, at the conclusion of the study, de-identified data will be submitted to the National Institute of Child Health and Development (NICHD) Data Repository to ensure public availability.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jill Demirci, PhD principal investigator
University of Pittsburgh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing AME and Video-based infant care education in people with Breastfeeding, run by University of Pittsburgh at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 19 Mar 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Breastfeeding Exclusivity (time frame: 2 weeks postpartum). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04258709, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Mar 2025.